Sequential administration of recombinant human interleukin-2 and dacarbazine in metastatic melanoma. A multicentre phase II study.

G Stoter, E Shiloni, S Aamdal, F J Cleton, S Iacobelli, J T Bijman, P Palmer, C R Franks, S Rodenhuis
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Abstract

Twenty-four evaluable patients with metastatic melanoma have been entered in a multicentre Phase II study of two induction cycles of human recombinant interleukin-2 (rIL-2) 18 x 10(6) IU/m2/day continuous i.v. bolus on days 1-5 and days 12-17. Dacarbazine (DTIC) 850 mg/m2 i.v. bolus was given on day 26. The cycle was repeated at five weeks. Maintenance therapy was scheduled three weeks after the completion of the induction treatment, consisting of rIL-2 18 x 10(6) IU/m2/day for five days alternating with DTIC 850 mg/m2 i.v., every three weeks, for a total of 18 weeks. Median age was 44 years (range 23-80), and Karnofsky index was 100 (range 80-100). One patient had received prior chemotherapy with hydroxyurea and one patient had prior radiotherapy. Six patients responded (25%): two had complete responses (CR) and four had partial responses (PR). Stable disease (SD) was seen in five patients. Responses occurred in the following sites: liver 2/9 (22%), lung 3/14 (21%), skin 2/11 (18%), and lymph nodes 3/12 (25%). Duration of CR was 11+ and 13 months. PRs lasted 2, 5, 7, and 11+ months. Of note, time to progression in patients with SD was similar to that of responders: 4, 4, 11+, 11+, and 14+ months. Toxicity included fever, skin rash, fatigue, anorexia, and diarrhoea in most patients. Two patients had a weight gain of more than 10%. Hypotension requiring vasoactive agents or interruption of rIL-2 occurred in four patients, creatinine elevations WHO grade 1-2 in seven patients, and bilirubin elevations WHO grade 1-3 in six patients. One patient developed transient ventricular tachycardia. It appears that rIL-2 and DTIC in this schedule is feasible and effective, but not clearly superior to rIL-2 alone.

重组人白细胞介素-2和达卡巴嗪序贯治疗转移性黑色素瘤。一项多中心II期研究。
24名可评估的转移性黑色素瘤患者进入了一项多中心II期研究,在1-5天和12-17天连续静脉注射人类重组白细胞介素-2 (il -2) 18 × 10(6) IU/m2/天两个诱导周期。第26天给予达卡巴嗪(DTIC) 850 mg/m2静脉注射。五周后重复这个循环。维持治疗计划在诱导治疗完成后3周进行,包括rIL-2 18 × 10(6) IU/m2/天,连续5天,与DTIC 850 mg/m2交替静脉注射,每3周,共18周。中位年龄44岁(范围23-80),Karnofsky指数为100(范围80-100)。1例患者既往接受过羟基脲化疗,1例患者既往接受过放射治疗。6例患者有反应(25%):2例完全缓解(CR), 4例部分缓解(PR)。5例患者病情稳定(SD)。以下部位有反应:肝脏2/9(22%),肺3/14(21%),皮肤2/11(18%),淋巴结3/12(25%)。CR持续时间分别为11+和13个月。治疗时间分别为2、5、7、11个月以上。值得注意的是,SD患者的进展时间与应答者相似:4,4,11 +,11+和14+个月。大多数患者的毒性包括发热、皮疹、疲劳、厌食和腹泻。两名患者的体重增加了10%以上。4例患者出现需要血管活性药物或il -2中断的低血压,7例患者出现肌酐升高WHO分级为1-2,6例患者出现胆红素升高WHO分级为1-3。一名患者出现短暂性室性心动过速。在此方案中,il -2和DTIC是可行和有效的,但并不明显优于单独使用il -2。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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